Vitamin E Level in Buccal Cells of Arsenicosis Patients
Primary Purpose
Chronic Arsenic Poisoning
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Arsenic Poisoning focused on measuring Arsenic, Arsenicosis, Buccal cells, Serum, Vitamin E, Cholesterol
Eligibility Criteria
Inclusion Criteria:
For arsenicosis
- who drank arsenic contaminated water (>50 µg/L) for more than 6 months
- having physical signs of moderate degree of melanosis and keratosis
For arsenic exposed control
- relative or family member of the patient
- showing no physical signs of melanosis and keratosis
- share same tube well water for drinking purpose for more than 6 months
For healthy volunteers
- who drank arsenic safe water (<50 µg/L)
- live in the same Upazilla
- have no cutaneous manifestation
- who voluntarily agree to participate
Exclusion Criteria:
- tuberculosis, eczema psoriasis, contact dermatitis
- patients getting treatment of arsenicosis
- subject who voluntarily do not agree to participate
Sites / Locations
- Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Arsenicosis patients
Arsenic exposed controls
Heathy volunteers
Arm Description
Vitamin E (200 IU, caplet) daily orally for 20 weeks
vitamin E (200 IU, caplet) daily orally for 20 weeks
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Outcomes
Primary Outcome Measures
Change in the amount of vitamin E in buccal cells
Changes in the amount of vitamin E in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Secondary Outcome Measures
Changes in the amount of cholesterol in buccal cells
Changes in the amount of cholesterol in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Changes in the concentration of vitamin E in serum
Changes in the concentration of vitamin E in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Changes in the concentration of cholesterol in serum
Changes in the concentration of cholesterol in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Full Information
NCT ID
NCT01743066
First Posted
December 1, 2012
Last Updated
December 4, 2012
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT01743066
Brief Title
Vitamin E Level in Buccal Cells of Arsenicosis Patients
Official Title
Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know the levels of vitamin E in patients chronically exposed to high concentration of arsenic and if changes are found, what happens when supplemented with vitamin E. The buccal cells and serum of patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E. Similar samples will be collected from similar number of arsenic exposed controls and healthy volunteers for comparison.
Detailed Description
Chronic consumption of arsenic through water (drinking and cooking) and food leads to accumulation of arsenic within the cell. We usually give emphasis on the skin manifestations (melanosis and keratosis) of arsenicosis that is diagnosed first. Other manifestations remain un-diagnosed or diagnosed later. The severe form is the development of cancer in different organs mainly skin, lungs and urinary bladder. To understand the pathophysiology of the development of clinical manifestations appearing in the skin first, we need to understand interior of cells other than skin. One of the dietary supplements, vitamin E is found to be effective in improving the clinical signs/symptoms of melanosis and keratosis. Buccal cells are also exposed to arsenic and easy to collect. To understand the pathogenesis, we need to know the levels of vitamin E in patients of arsenicosis and if changes, what happens when supplemented with vitamin E. The buccal cells and serum of 20 patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E (200 IU, caplet) daily orally for 20 weeks. Similar samples will be collected from 20 arsenic exposed controls and 20 healthy volunteers for comparison.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Arsenic Poisoning
Keywords
Arsenic, Arsenicosis, Buccal cells, Serum, Vitamin E, Cholesterol
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arsenicosis patients
Arm Type
Experimental
Arm Description
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Arm Title
Arsenic exposed controls
Arm Type
Active Comparator
Arm Description
vitamin E (200 IU, caplet) daily orally for 20 weeks
Arm Title
Heathy volunteers
Arm Type
Active Comparator
Arm Description
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
vitamin E (200 IU, caplet) daily orally for 20 weeks
Primary Outcome Measure Information:
Title
Change in the amount of vitamin E in buccal cells
Description
Changes in the amount of vitamin E in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)
Secondary Outcome Measure Information:
Title
Changes in the amount of cholesterol in buccal cells
Description
Changes in the amount of cholesterol in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)
Title
Changes in the concentration of vitamin E in serum
Description
Changes in the concentration of vitamin E in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)
Title
Changes in the concentration of cholesterol in serum
Description
Changes in the concentration of cholesterol in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For arsenicosis
who drank arsenic contaminated water (>50 µg/L) for more than 6 months
having physical signs of moderate degree of melanosis and keratosis
For arsenic exposed control
relative or family member of the patient
showing no physical signs of melanosis and keratosis
share same tube well water for drinking purpose for more than 6 months
For healthy volunteers
who drank arsenic safe water (<50 µg/L)
live in the same Upazilla
have no cutaneous manifestation
who voluntarily agree to participate
Exclusion Criteria:
tuberculosis, eczema psoriasis, contact dermatitis
patients getting treatment of arsenicosis
subject who voluntarily do not agree to participate
Facility Information:
Facility Name
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
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Vitamin E Level in Buccal Cells of Arsenicosis Patients
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